Neuromuscular Electrical Stimulation (NMES) - CAM 014

Description:
Neuromuscular electrical stimulation (NMES) involves the use of a device which transmits an electrical impulse to the skin over muscle groups by way of electrodes. This technology is proposed to stimulate the muscle while the individual is in a resting state to prevent or treat muscle atrophy and is indicated for individuals with intact nerve supply to the muscle. This technology differs from Functional Neuromuscular Electrical Stimulation (addressed in a separate policy) which is proposed for use in individuals who are neurologically impaired (e.g., stroke, spinal cord injury).

When subjected to insufficient use, muscles atrophy, resulting in a loss of strength and mass. Muscle atrophy may occur when the limbs are immobilized after injury or surgery (e.g., casting or splinting of limb, contracture due to scarring of soft tissue as in burn lesions, hip replacement surgery). The NMES device is proposed to stimulate the motor nerves with electrical currents, generating muscle contractions to reverse muscle atrophy. The intensity and frequency of stimulation can vary based on the level of muscular function and treatment response. Examples of devices that have received 510(k) marketing clearance for the treatment of muscle atrophy include RS Medical’s RS-2m™ 2-channel and RS-4m® 4-channel muscle stimulator.

Neuromuscular electrical stimulation has also been studied in the treatment of spastic muscles related to cerebral palsy and spina bifida. For this indication, the stimulation is not intended to cause muscle contraction. Although the mechanism of action is not understood, it is thought that low-intensity stimulation (sub-threshold level) may increase muscle strength and joint mobility, leading to improved voluntary motor function. This technique is referred to threshold electrical stimulation.

H-wave stimulation is a distinct form of electrical stimulation that has been investigated primarily for treatment of pain from a variety of etiologies including diabetic neuropathy, muscle sprains, temporomandibular joint dysfunction (TMJ), and reflex sympathetic dystrophy (RSD). H-wave stimulation has also been used to accelerate wound healing such as diabetic ulcers and to improve range of motion and function to prevent muscle atrophy after orthopedic surgery. This technology produces a direct, localized effect on the conduction of underlying peripheral nerves and may be used in the home setting. It differs from transcutaneous electrical nerve stimulation (TENS) in terms of the wave form.

Policy:
FDA approved neuromuscular stimulator devices may be considered MEDICALLY NECESSARY when prescribed for disuse muscular atrophy from prolonged immobilization and that is present in the setting of an intact nerve supply to the muscle, including brain, spinal cord and peripheral nerves. 

A neuromuscular stimulator garment is considered NOT MEDICALLY NECESSARY.  

Neuromuscular stimulation is considered NOT MEDICALLY NECESSARY for: 

  • Prevention of muscle atrophy, e.g., following an orthopedic procedure.
  • Treatment of pain for various musculoskeletal conditions, including, but not limited to patellofemoral syndrome, spinal stenosis, lumbago, muscle strains/sprains.
  • As a technique to increase circulation. 
  • H wave Stimulation.
  • Threshold Electrical Stimulation.

Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be investigational/unproven therefore considered NOT MEDICALLY NECESSARY.

Contraindications:
NMES/FES is contraindicated for members with SCI with ANY of the following:
 

  1. Cardiac pacemakers
  2. Severe scoliosis
  3. Severe osteoporosis
  4. Skin disease or cancer at area of stimulation
  5. Irreversible contracture
  6. Autonomic dysreflexia

Rationale:
In 2010, Monaghan and colleagues reviewed available literature assessing the effectiveness of NMES in regards to quadricep strength before and after total knee replacement. The studies had no significant differences reported for maximum voluntary isometric torque or endurance between the NMES group and the control group. In one study there was a difference in quadriceps muscle activation in the group with NMES and exercise from the control group utilizing exercise alone. This difference was much more significant at 6 weeks than at 12 weeks. Further analysis was not possible related to the absence of raw data scores. The authors concluded that the available studies preclude any conclusions regarding NMES quadriceps strengthening pre- and post-op total knee replacement.

In 2010, a study was conducted evaluating the effect of NMES on quadriceps muscle strength and activation in women with mild and moderate osteoarthritis by Palmieri-Smith and colleagues. The was a treatment and a non-treatment group. The treatment group received NMES 3 times a week for 4 weeks. At the conclusion of the study, no improvement was noted in the treatment group. 

In 2012 results of a post TKA NMES quadriceps study were published. This study conducted by Stevens-Lapsley and colleagues initiated NMES 48 hours post TKA in addition to standard rehabilitation. Subjects were randomly assigned to either NMES and standard rehabilitation or standard rehabilitation. Significant improvement in the NMES group was noted in quadriceps and hamstring strength at 3.5 weeks post op. There was also improved functional performance, knee extension and active range of motion noted. Authors concluded that early addition of NMES reduced loss of quadriceps muscle strength and improved functional performance following TKA. Results persisted through 52 weeks post op, but, were most notable in the first post operative month. As this was a small study with volumes not matched in both arms of the study, the authors stated further research is warranted regarding early intervention with NMES after TKA. 

Numerous clinical trials are currently on going regarding NMES. They include studies related to multiple sclerosis, cerebral palsy, hemiparetic patients and ICU associated weakness. Several studies have recently been completed with data not yet published. 

The principal outcomes associated with treatment of pain due to any cause may include: relief of pain, improved functional level, and return to work. Relief of pain is a subjective outcome that is typically associated with a placebo effect. Therefore, data from adequately powered, blinded, randomized controlled trials (RCTs) are required to control for the placebo effect, determine its magnitude, and determine whether any treatment effect from an electrical stimulation device provides a significant advantage over the placebo. 

Treatment with an electrical stimulation device must also be evaluated in general groups of patients against the existing standard of care for the condition being treated. For example, in patients with pain symptoms, treatment with an electrical stimulation device should be compared with other forms of conservative therapy such as splinting, rest, non-steroidal anti-inflammatory medications, physical therapy, or steroid injection.

SYSTEMATIC REVIEW
Williamson (2021) published a review of pre-clinical (animal) and clinical studies evaluating the H-Wave® device in the treatment of acute, chronic, or post-surgical musculoskeletal pain or loss of function.1 Sixteen studies were included in the review, however only nine of the studies reported clinical data (N = 6,789). The trials, small cohort studies and case reports are summarized below. The authors summarized study outcomes of reduced pain, improved function, and lower medication use with the device. The certainty of evidence assessed for all studies was low to moderate with study weaknesses including moderate risk of bias and lack of objective clinical findings noted. No pooled analyses were conducted. 

A systematic review with meta-analysis, supported in part by a device manufacturer (Electronic Waveform Lab, Inc.) was published in 2008 and reported on five studies using the H-Wave device for the treatment of pain.2 However, conclusions based on this meta-analysis are limited by the lack of sufficient data from randomized, placebo-controlled studies and are based mainly upon results from case series. 

RANDOMIZED CONTROLLED TRIALS 
Two small RCTs (n = 23 and 31) evaluated the efficacy of H-wave electrical stimulation in the treatment of diabetic peripheral neuropathy, a follow-up survey reported outcomes of patients who continued H-wave electrical stimulation for more than one year, and one small study evaluated the effects of H-wave stimulation on range of motion and strength testing in patients who underwent rotator cuff reconstruction.3,4,5,6 The generalizability of the findings in these studies is limited due to at least one of the following reasons:

  • The small study population limited the ability to rule out the role of chance as an explanation of findings.
  • The attrition of study subjects and blinding was either not reported or not adequately addressed in the analysis, potentially undermining comparability of treatment groups.

Definitions:
TENS: Transcutaneous Electrical Nerve Stimulator is a device used to treat chronic intractable pain, and pain associated with active or post-traumatic injury unresponsive to other standard pain therapies. The device is applied to the surface of the skin at the site of the pain. It consists of an electrical pulse generator, usually battery operated, connected by a wire to two or more electrodes. A programmable stimulator may be programmed in advance to stimulate at regular times or upon demand by the use of a hand held magnet over the stimulator. (Neuro Cybernetic Prosthesis System)
 

MNS: Microcurrent Nerve Stimulator works on the same principal as TENS by delivering microcurrent instead of regular current. 

PENS: Percutaneous Nerve Stimulator is similar to TENS, with the exception that instead of electrodes attached to the skin near the pain area, in PENS, a needle is inserted into the pain site. 

PNT: Percutaneous neuromodulation therapy is a variant of PENS in which up to 10 fine filament electrodes are temporarily placed at specific anatomical landmarks in the back. Treatment regimens consist of 30-minute sessions, once or twice a week for 8 to 10 sessions. 

VNS: Implanted vagus nerve stimulation (VNS) devices have been used to treat patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed. Surgery for implantation of the VNS device is done with the patient under either general anesthesia or regional cervical block. Since right vagus nerve stimulation produces bradycardia, implantation is limited to left-sided unilateral implantations. Two spiral electrodes are implanted around the left vagus nerve within the carotid sheath, which are connected to an infraclavicular generator pack. A programmable stimulator may be programmed in advance to stimulate at regular times or upon demand by the use of a hand held magnet over the stimulator. (Neuro Cybernetic Prosthesis System) 

FNS: Functional Neuromuscular Stimulation attempts to replace stimuli from destroyed nerve pathways with electrical stimulation to the muscles. It is presumed that electric stimulation enables the spinal cord injured patient to stand or walk independently or to maintain healthy muscle tone and strength. 

NMES: Neuromuscular Electric Stimulator for disuse atrophy. NMES involves the use of a device that transmits an electrical impulse to activate muscle groups by way of electrodes. There are two broad categories of NMES. One type of device stimulates the muscle when the patient is in a resting state to treat muscle atrophy. The second type is used to enhance functional activity of neurologically impaired patients. 

Spinal Cord Stimulation for Chronic Pain: Electrodes are implanted in the epidural space to stimulate the dorsal column and treat chronic pain. 

DBS: Deep Brain Stimulation of the thalamus has been used as an alternative to permanent neuroablative procedures such as thalamotomy and pallidotomy for control of essential tremor, and tremors associated with Parkinson's disease. It involves stereotactic placement of an electrode into the brain, which is attached to a temporary transcutaneous cable for short-term stimulation to validate treatment effectiveness. Several days later a permanent subcutaneous programmable stimulator is implanted. DBS of the globus pallidus and subthalamic nucleus has also been investigated for other symptoms of Parkinson's disease such as rigidity, bradykinesia or akinesia. DBS is also FDA approved for the treatment of dystonia. 

H-Wave® Electric Stimulation: This device is used for the treatment of pain related to a variety of etiologies. This is also used for wound healing. 

Sensory Stimulation for Coma Patients: Sensory stimulation is intended to enhance awakening and rehabilitative potential of coma patients. Treatment may be delivered in the hospital, the patient's home, or a nursing home by professionals including nurses, occupational therapist, physical therapist, speech language therapist and even by a trained family member. 

TES: Threshold Electric Stimulator as a treatment of motor disorders. Low intensity electrical stimulation is used to target spastic muscles during sleep at home. Although the exact mechanism of action is not known, it is presumed that it may increase muscle strength and joint mobility leading to improved voluntary motor function. This is used in children with spastic paraplegia related to cerebral palsy and also in those with other motor disorders, such as spina bifida. 

Sympathetic therapy as a treatment of chronic pain (i.e., Dynatron STS): Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to 'normalize' the autonomic nervous system and alleviate chronic pain. Sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain. 

Interferential current stimulation (IFC) is a type of electrical current treatment that uses paired electrodes of two independent medium-frequency alternating currents. The electrodes are arranged on the skin so the current flowing between each pair intersects at the underlying target. IFC has been investigated as a technique to reduce pain, improve range of motion, or promote local healing. 

LymphavisionTM is an electrical stimulation device that stimulates smooth muscles thereby promoting lymphatic flow. It is described as a treatment for such conditions as diabetic foot syndrome and trophic ulcers, and prevention of deep vein thrombosis. 

TEJS: Transcutaneous electrical joint stimulation is the application of a signal-specific electrical current to the joint tissue to relive the signs and symptoms of osteoarthritis of the knee. Two electrode patches are worn for six to ten hours a day, preferably while the patient is sleeping. TEJS has been indicated as adjunctive therapy for patients who have failed NSAIDS, those with moderate to severe disease despite best medical therapy, and those with severe disease who are not surgical candidates for reasons such as morbid obesity and inappropriate age. 

PES: Pulsed electrical stimulation is provided by an electronic device that noninvasively delivers a low voltage, monophasic electrical field to the targeted area of pain. It is used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard forms of treatment.

References:

  1. American Academy of Orthopaedic Surgeons. (2013). Treatment of osteoarthritis of the knee (evidence-based guideline, 2nd edition). Retrieved August 20, 2018 from https://www.aaos.org.  
  2. Blum, K., Chen, A., Chen, T., Waite, R., Downs, B., Braverman, E., et al. (2009). Repetitive H wave device stimulation and program induces significant increases in the range of motion of post-operative rotator cuff reconstruction in a double blinded randomized placebo controlled human study. BMC Musculoskeletal Disorders, 10, 132. (Level 2 evidence)
  3. Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for neuromuscular electrical stimulation (NMES) (160.12). Retrieved July 7, 2020 from http://www.cms.gov.   
  4. Gatewood, C.T., Tran, A.A., & Dragoo, J.L. (2017). The efficacy of post-operative devices following knee arthroscopic surgery: a systematic review. Knee surgery, Sports Traumatology, Arthroscopy, 25 (2), 501-516. Abstract retrieved August 16, 2018 from PubMed database.
  5. Salazar, AP., Pagnussat, AS., Pereira, GA., Scopel, G., & L, JL. (2019). Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. Brazilian Journal of Physical Therapy, 23 (5), 378-386. (Level 1 evidence)
  6. Stevens-Lapsley, J., Balter, J., Wolfe, P., Eckhoff, D., & Kohrt, W. (2012). Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Physical Therapy, 92 (2), 210-226. (Level 2 evidence)
  7. Toth, M.J., Tourville, T.W., Voigt, T.B., Choquette, R.H., Anair, B.M., Falcone, M.J.,  et al. Utility of neuromuscular electrical stimulation to preserve quadriceps muscle fiber size and contractility after anterior cruciate ligament injuries and reconstruction: A randomized, sham-controlled, blinded trial. American Journal of Sports Medicine, 48 (10), 2429-2437. (Level 2 evidence)
  8. U. S. Food and Drug Administration. (2002, May). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K021763. Retrieved August 17, 2018 from http://www.accessdata.fda.gov. 
  9. Yue, C., Zhang, X., Zhu, Y., J, W., Wang, H., Liu, Y., et al. (2018). Systematic review of three electrical stimulation techniques for rehabilitation after total knee arthroplasty. The Journal of Arthroplasty, 33 (7), 2330-2337. Abstract retrieved July 8, 2020 from PubMed database.
  10. TK Williamson, HC Rodriguez, A Gonzaba, N Poddar, SM Norwood, A Gupta. H Wave((R)) Device Stimulation: A Critical Review. J Pers Med. 2021;11(11). PMID: 34834486
  11. K Blum, AL Chen, TJ Chen, et al. The H-Wave device is an effective and safe non pharmacological analgesic for chronic pain: a meta-analysis. Adv Ther. 2008;25(7):644-57. PMID: 18636234
  12. D Kumar, HJ Marshall. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997;20(11):1702-5. PMID: 9353612
  13. D Kumar, MS Alvaro, IS Julka, HJ Marshall. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care. 1998;21(8):1322-5. PMID: 9702441
  14. K Blum, AL Chen, TJ Chen, et al. Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC Musculoskelet Disord. 2009;10:132. PMID: 19874593
  15. IS Julka, M Alvaro, D Kumar. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. J Foot Ankle Surg. 1998;37(3):191-4. PMID: 9638542

Coding Section

Codes

Number

Description

CPT 

97014

Application of a modality to one or more areas; electrical stimulation (unattended)

 

97024

Application of a modality to one or more areas; diathermy (e.g., microwave)

 

97032

Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes

ICD-9 Diagnosis 

728.2

Muscular wasting and disuse atrophy, not elsewhere classified (see criteria)

 

709.2

Scar conditions and fibrosis of skin

 

717.0 - 717.9

Internal derangement of knee

 

718.40 - 718.49

Contracture of joint

 

906.6 - 906.7

Late effects of burns

 

V43.64

Joint replaced by other means, hip

 

V43.65

Joint replaced by other means, knee

HCPCS

A4556

Electrodes (e.g., apnea monitor), per pair

 

A4557

Lead wires (e.g., apnea monitor), per pair

 

A4558

Conductive gel or paste, for use with electrical device (e.g., TENS, NMES), per oz.

 

A4595

Electrical stimulator supplies, 2 lead, per month, (e.g., TENS, NMES)

 

E0745

Neuromuscular stimulator, electronic shock unit

 

L8680

Implantable neurostimulator electrode, each

 

L8681

Patient programmer (external) for use with implantable programmable neurostimulator pulse generator

 

L8682

Implantable neurostimulator radiofrequency receiver

 

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

 

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

 

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

 

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

 

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

 

L8689

External recharging system for battery (internal) for use with implantable neurostimulator

ICD-10-CM (effective 10/01/15)

M62.50 

Muscle wasting and atrophy, not elsewhere classified, unspecified site 

ICD-10-PCS (effective 10/01/15) 

L90.5 

Scar conditions and fibrosis of skin 

 

M23.205

Derangement of unspecified medial meniscus due to old tear or injury, unspecified knee 

 

M23.219 

Derangement of anterior horn of medial meniscus due to old tear or injury, unspecified 

 

M23.319 

Other meniscus derangements, anterior horn of medial meniscus, unspecified knee 

 

M23.239 

Derangement of other medial meniscus due to old tear or injury, unspecified knee 

 

M23.305 

Other meniscus derangements, unspecified medial meniscus, unspecified knee 

 

M23.339 

Other meniscus derangements, other medial meniscus, unspecified knee 

 

M23.009 

Cystic meniscus, unspecified meniscus, unspecified knee 

 

M23.40 

Loose body in knee, unspecified knee 

 

M22.40 

Chondromalacia patellae, unspecified knee 

 

M23.90 

Unspecified internal derangement of unspecified knee 

 

M24.50 

Contracture, unspecified joint 

 

M24.519 

Contracture, unspecified shoulder 

 

M24.539 

Contracture, unspecified wrist 

 

M24.549 

Contracture, unspecified hand 

 

M24.559

Contracture, unspecified hip

 

M24.569

Contracture, unspecified knee

 

M24.573

Contracture, unspecified ankle

 

M24.576

Contracture, unspecified foot

 

T23.009S

Burn of unspecified degree of unspecified hand, unspecified site, sequela

 

T23.079S

Burn of unspecified degree of unspecified wrist, sequela

 

T23.409S

Corrosion of unspecified degree of unspecified hand, unspecified site, sequela

 

T23.479S

Corrosion of unspecified degree of unspecified wrist, sequela

 

T22.00XS

Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

 

T22.40XS

Corrosion of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

 

T24.009S

Burn of unspecified degree of unspecified site of unspecified lower limb, except ankle and foot, sequela

 

T24.409S

Corrosion of unspecified degree of unspecified site of unspecified lower limb, except ankle and foot, sequela

 

Z96.649

Presence of unspecified artificial hip joint

 

Z96.659

Presence of unspecified artificial knee joint

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

09/01/2023 Annual review, reformmatting policy verbiage, but, no change to intent. 

09/06/2022

Annual review, adding H wave stimulation to list of not medically necessary items. Also updating description, rationale and references.

03/23/2022 

Updating Coding section. Removing CPT Codes 64553-64566 AND 64580. No other changes made. 

11/15/2021 

Updating coding. Code 64550 has been deleted. Adding codes 64553, 64555, 64561 and 64566. No other changes made. 

09/01/2021 

Annual review, no change to policy intent.

09/01/2020 

Annual review, no change to policy intent. 

09/03/2019 

Annual review, no change to policy intent. 

08/22/2018 

Annual review, no change to policy intent. 

06/13/2018 

correcting a typo on Date Last Reviewed. No other changes made.

06/04/2018

Interim review to update policy. Removing the following verbiage:

As a component of post-operative rehabilitation in either of the following settings: 

When muscular atrophy is present before an orthopedic intervention (i.e., repair of anterior cruciate ligament). In this setting, neuromuscular stimulation may be initiated immediately in the post-op phase as an adjunct to physical therapy;

When muscular atrophy develops in the post-operative period. Individuals meeting this criterion typically are participating in a physical therapy program, but have experienced complications related to the surgery, which preclude successful physical therapy. In this setting, neuromuscular stimulation may be initiated only after the development of muscle atrophy.

09/07/2017 

Annual review, no change to policy intent. 

09/01/2016 

Annual review, no change to policy intent. 

09/16/2015 

Annual review, no change to policy intent. Added coding.

09/25/2014

Correct typo errors.

09/22/2014

Annual review, no changes made.

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